A Food and Drug Administration (FDA) fact sheet distributed with the Johnson & Johnson (J&J) vaccine will now contain warning language about a small increased risk that vaccine recipients have of developing Guillain-Barré syndrome (GBS), a neurologic disorder that can cause progressive, but usually reversible, paralysis.
So far, the FDA has said there have been 100 cases identified in 12.8 million US J&J recipients, mostly in men over the age of 50.
The FDA's fact sheet said patients who have developed GBS show symptoms within 42 days of inoculation, and said recipients should call health providers immediately if they develop numbness, difficulty walking, or loss of bladder control.
"Although the available evidence suggests an association between the Janssen [J&J] vaccine and increased risk of GBS, it is insufficient to establish a causal relationship. No similar signal has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines," the labeling reads.
This is not the first time GBS has been tied to vaccine administration. GBS was linked to administration of the swine flu vaccine in 1976, some shingles vaccines, and seasonal flu vaccines. An estimated 3,000 to 6,000 people develop GBS in the United States annually, with most cases linked to viral or bacterial infections of the respiratory or gastrointestinal tracts.
According to information from the FDA given to CNN, 95 of the 100 reports of GBS involved people who needed hospitalization, and 1 person died.
In a short statement, Johnson & Johnson said yesterday, "We strongly support raising awareness of the signs and symptoms of rare events to ensure they can be quickly identified and effectively treated."
Feds ask for more data on boosters
After a 1-hour meeting yesterday between Pfizer’s top scientists and White House medical advisors and regulatory officials, the Biden administration said it needs more data on the potential benefits of a third booster vaccine dose.
Pfizer pointed to data from small clinical trials and real-world numbers from Israel as evidence that a third dose can help raise antibody levels and protect recipients from emerging variants. Officials said, however, that they need more information such as more data on breakthrough infections (infections in vaccinated people) before they can make a decision.
Insiders in both the Biden administration and at the World Health Organization argue countries need to be more concerned with offering the initial series of vaccine before distributing boosters.
The Centers for Disease Control and Prevention (CDC) COVID Data Tracker shows 387,006,120 COVID-19 vaccine doses have been delivered in the United States and 334,600,770 doses have been administered. Almost 159.5 million Americans are fully vaccinated (159,499,224), and 67.7% of adults have at least one dose.
The United States reported 32,765 new COVID-19 cases yesterday, and 236 deaths, according to the Johns Hopkins COVID-19 tracker. The 7-day average of new COVID-19 cases in the United States is 23,369, according to the Washington Post.
Summer camp outbreaks
As summer activities continue amidst the circulating Delta variant (B1617.2), the country has seen a string of COVID-19 outbreaks tied to summer camps in places such as Texas, Illinois, Florida, Missouri, and Kansas, the Associated Press reports.
Experts worry the summer camp cases foretell possible school outbreaks in the fall. Children 11 and under in the United States are still not eligible for the COVID-19 vaccine.
And more hot spots are developing as the Delta variant takes hold of some major cities and regions: A surge of COVID-19 cases and hospitalizations in Florida is being driven by outbreaks in the Miami area, Jacksonville, and the Panhandle, the Miami Herald reports. Hospitals in southwest Missouri are also beginning to surpass the level of COVID-19 patients seen in the winter, according to the St. Louis Post-Dispatch.
Mandating COVID vaccines in healthcare
Today the Society for Healthcare Epidemiology of America (SHEA) released a consensus statement saying COVID-19 vaccines should be required for all healthcare personnel and hospital employees.
"Vaccinating the healthcare workforce reduces the risk of transmission by protecting patients, healthcare personnel, and communities, and maintains trust in healthcare providers and healthcare institutions," said David J. Weber, MD, MPH, a member of the SHEA Board of Trustees and lead author of the statement.
SHEA said requiring vaccines as a condition of employment raises uptake. In healthcare settings where seasonal flu vaccines are required, compliance rose to 94.4% compared to 69.6% in organizations without a requirement.
